EDANA’s position on the findings of the recent South African study
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EDANA’s position on the findings of the recent South African study
EDANA, the international association representing the nonwovens and related industries, is aware of a recently published academic study examining the presence of certain chemical substances in menstrual products sold in South Africa. It is important to note that the study reflects conditions specific to South Africa, including local environmental and regulatory factors, and should be interpreted within this geographic context.
The safety of menstrual products is, and will always remain, the industry’s top priority. All menstrual products manufactured by EDANA members are designed to be safe, to comply with applicable national and international regulatory frameworks, and to undergo rigorous exposure-based safety assessments before reaching the markets.
The substances discussed in the study are not intentionally added to menstrual products. The trace amount detected in the study is extremely low, consistent with background environmental presence. To address the concerns raised in the past days, it is important to move beyond the simple presence or absence of a substance and consider what detection means in terms of realistic consumer exposure and health relevance.
BACKGROUND INFORMATION
1. Testing must always be comprehensive and multi-faceted.
The substances discussed in the study are not intentionally added to menstrual products but may originate from environmental contamination.
Where extremely low trace amounts may be detected, in parts per billion, they are consistent with background environmental presence and do not indicate health risk; they do not and cannot serve any functional purpose in these products.
It is essential to distinguish between detection, hazard, and risk. Analytical methods used in recent studies measure the total content of a substance within a material. However, detection of a substance does not in itself indicate a safety concern nor that consumers are exposed to it.
Robust safety evaluation requires assessing the migratable fraction—the amount that may transfer to the user under realistic conditions of use—rather than total content alone. The absorbent hygiene product industry applies Exposure-Based Risk Assessment (EBRA)1 frameworks aligned with principles established by the World Health Organization (WHO)2, and the European Chemicals Agency (ECHA)3. These approaches evaluate and are built upon actual consumer exposure.
2. Methodology should be harmonised and conclusive.
Furthermore, it is important that scientific findings are interpreted in the context of real-world use conditions. Laboratory methods designed to maximize detection, such as the method used in the South African study, do not reflect consumer exposure during normal use under which consumers use these products. Established industry standards are specifically designed to assess safety under realistic conditions.
Harsh organic solvent extraction is appropriate for determining total chemical content within a material, but it does not reflect realistic consumer exposure conditions. The use of solvents such as methanol can dissolve or swell polymer fibres and adhesives, releasing substances that would otherwise remain bound within the material and are unlikely to migrate to the consumer’s skin or mucosa under normal use.
The absorbent hygiene product industry supports harmonised, consumer-relevant test methods, including those described in the CEN CWA 18062 standard4, developed in collaboration with the European Committee for Standardization (CEN) and recognised by the European Commission as a useful analytical tool for assessing the safety of consumer products under the General Product Safety Regulation (GPSR). This protocol uses aqueous biological fluid simulants (mimicking menses) at body temperature (37°C) for 16 hours with agitation to assess potential migration under realistic conditions.
This harmonised approach is designed to be robust, reproducible and focused on consumer-relevant exposure under realistic conditions of use.
In 2020, EDANA and its members launched a voluntary Stewardship Programme to enhance transparency and strengthen consumer confidence by going beyond existing EU and national legislation. The classes of chemicals mentioned in recent studies are already being monitored by EDANA and its members.
At the core of the programme is the CODEX6, which establishes guidance values for selected trace chemicals, based on the relevance for the AHP sector and its consumers. These substances are chosen based on their potential occurrence in the supply chain or because they are subject to regulatory scrutiny or consumer concern. The guidance values represent minimum levels that signatories commit not to exceed and are derived from established regulatory benchmarks in related sectors, like for instance OEKO-TEX® Standard 100.
Through continuous innovation, reduction of residual substances to the absolute minimum, exposure-based risk assessment, and proactive stewardship via EDANA’s Stewardship Programme for AHPs, the absorbent hygiene product industry helps ensure that menstrual products continue to provide health protection, comfort, and dignity to millions of individuals worldwide. Ongoing dialogue with regulators and the scientific community should remain grounded in rigorous scientific principles to ensure that consumer confidence is supported by evidence.
EDANA’s stewardship framework and test methods are designed to account for variability across different markets, ensuring that safety assessments remain relevant and robust globally.
References:
[1]https://www.edana.org/how-we-take-action/edana-stewardship-programme-for-absorbent-hygiene-products/the-edana-absorbent-hygiene-product-stewardship-programme-codex/test-methods
[2]https://iris.who.int/items/ee11873f-59a6-4698-91cc-267e41c72053
[3]https://echa.europa.eu/documents/10162/17224/information_requirements_r14_en.pdf/bb14b581-f7ef-4587-a171-17bf4b332378?t=1471952253181
[4]https://www.edana.org/how-we-take-action/edana-stewardship-programme-for-absorbent-hygiene-products/the-edana-absorbent-hygiene-product-stewardship-programme-codex/test-methods
[5]https://www.edana.org/hubfs/Advocacy_Regulatory%20Affairs/regulatory-affairs/Explanation%20on%20the%20EDANA%20Stewardship%20Program.pdf?hsLang=en
[6]codex stewardship program AHP May2025.pdf